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CTRI Number  CTRI/2025/12/098761 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Process of Care Changes
Behavioral 
Study Design  Other 
Public Title of Study   A study to see if a 3D video experience can help patients feel calmer before their heart blood vessel test 
Scientific Title of Study   Effectiveness of virtual reality of preoperative information on anxiety level and hemodynamic among patient undergoing coronary angiography at a selected hospital in Mangalore 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Veeresh Kademani 
Designation  Lecturer 
Affiliation  Lecturer, Department of Medical-Surgical Nursing, Nitte Usha Institute of Nursing Sciences (NUINS), Nitte (Deemed to be University), Mangalore. 
Address  Department of Medical Surgical Nursing, Nitte Usha Institute of Nursing Sciences (NUINS), Nitte (Deemed to be University), Room No.:1, Academic Block of Paneer Campus, Deralakatte Mangalore.

Dakshina Kannada
KARNATAKA
575022
India 
Phone  08660871279  
Fax    
Email  omveeru007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Veeresh Kademani 
Designation  Lecturer 
Affiliation  Lecturer, Department of Medical-Surgical Nursing, Nitte Usha Institute of Nursing Sciences (NUINS), Nitte (Deemed to be University), Mangalore. 
Address  Department of Medical Surgical Nursing, Nitte Usha Institute of Nursing Sciences (NUINS), Nitte (Deemed to be University), Room No.:1, Academic Block of Paneer Campus, Deralakatte Mangalore.

Dakshina Kannada
KARNATAKA
575022
India 
Phone  08660871279  
Fax    
Email  omveeru007@gmail.com  
 
Details of Contact Person
Public Query  
Name  Veeresh Kademani 
Designation  Lecturer 
Affiliation  Lecturer, Department of Medical-Surgical Nursing, Nitte Usha Institute of Nursing Sciences (NUINS), Nitte (Deemed to be University), Mangalore. 
Address  Department of Medical Surgical Nursing, Nitte Usha Institute of Nursing Sciences (NUINS), Nitte (Deemed to be University), Room No.:1, Academic Block of Paneer Campus, Deralakatte Mangalore.

Dakshina Kannada
KARNATAKA
575022
India 
Phone  08660871279  
Fax    
Email  omveeru007@gmail.com  
 
Source of Monetary or Material Support  
Justice K.S. Hegde Charitable Hospital, Deralakatte, Mangalore – 575018, Karnataka, India 
Nitte (Deemed to be University), 6th Floor, University Enclave, Medical Sciences Complex, Deralakatte, Mangalore - 575018, Karnataka, India.  
 
Primary Sponsor  
Name  Veeresh Kademani  
Address  Nitte (Deemed to be University), 6th Floor, University Enclave, Medical Sciences Complex, Deralakatte, Mangalore - 575018, Karnataka, India. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Latha S  Justice K S Hegde Charitable Hospital. Mangalore  Nitte (Deemed to be University), 6th Floor, University Enclave, Medical Sciences Complex, Deralakatte, Mangalore - 575018, Karnataka, India.
Dakshina Kannada
KARNATAKA 		 7349709417

latha@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nitte (Deemed to be Univeristy), Ethics Committee, Nitte Usha Institute of Nursing Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I708||Atherosclerosis of other arteries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard preoperative care (Control group): Participants in the control group will receive routine preoperative care as per hospital protocol.   Participants allocated to the control group will receive standard preoperative care strictly as per the existing hospital protocol for patients scheduled for coronary angiography, without exposure to any structured educational program, audiovisual teaching, or virtual reality–based intervention. After the patient is posted for the procedure, the investigator will explain the nature and purpose of the study, and written informed consent will be obtained prior to enrollment. A pre-test assessment will then be conducted to collect baseline demographic and clinical data using a structured proforma, along with assessment of anxiety levels using a standardized state and trait anxiety tool and measurement of baseline hemodynamic parameters including blood pressure, heart rate, and oxygen saturation under resting conditions. Thereafter, participants will continue to receive routine preoperative care, which includes verification of identity, documentation of procedural consent, review of investigations, medical fitness assessment, fasting and medication instructions, and routine unstructured verbal information provided by ward nurses. The post-test assessment will be conducted just before shifting the patient to the catheterization laboratory using the same anxiety assessment tool and hemodynamic measurement methods. Confidentiality will be maintained throughout the study, and participants will retain the right to withdraw at any time without affecting their treatment or care. 
Intervention  Virtual reality based preoperative information  Participants allocated to the intervention arm will receive virtual reality (VR)–based preoperative information prior to undergoing coronary angiography, in addition to routine hospital care. Before enrolment into the study, each eligible participant will be provided with a detailed Patient Information Sheet (PIS) explaining the purpose of the study, nature of the intervention, procedures involved, potential benefits, possible risks, confidentiality of data, and the voluntary nature of participation. After ensuring adequate understanding, written informed consent will be obtained from all participants. The pretest assessment will be conducted once the patient is selected and scheduled for coronary angiography, before administering the VR intervention. Baseline measurements of anxiety level will be assessed with state trait anxiety inventory scale and hemodynamic parameters (including heart rate, blood pressure, and oxygen saturation) will be recorded using sphygmomanometer and pulse oximeter monitoring equipment. Following the pretest, the participant will undergo a structured immersive three-dimensional virtual reality experience in the Kannada language, designed to familiarize the patient with the entire procedural pathway in a realistic and reassuring manner. The VR experience begins at the entrance of the cardiology ward, proceeds through the hospital corridor, and enters the cardiac catheterization laboratory. It demonstrates the fluoroscopy unit, patient monitoring systems, operating table, sterile environment, and procedural lighting. The simulation explains patient positioning on the angiography table and visually introduces the angiography procedure in a simple, non-threatening manner. This is followed by the transfer to the Cardiac Intensive Care Unit (CICU) and later to the general ward, explaining post-procedure monitoring, recovery process, and nursing care. Throughout the session, step-by-step audio narration in Kannada provides procedural clarity and reassurance to enhance psychological preparedness. The duration of the VR session is approximately 9 minutes, and it is delivered once only, prior to the procedure, using a Meta Quest 3,virtual reality headset to ensure full immersion. The session will be administered by the investigator or trained research personnel, with the patient seated comfortably and monitored for safety. The posttest assessment will be conducted after the completion of the VR session and just before the patient is shifted to the cardiac catheterization laboratory (cath lab). The same standardized tools and monitoring methods used during the pretest will be employed to reassess the anxiety level and hemodynamic parameters, ensuring consistency and reliability of measurements. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  Participants who are scheduled for elective coronary angiography.
Participants who can understand and follow instructions in Kannada.
Participants who are willing to participate and provide informed consent.
Participants with stable hemodynamic status at the time of enrolment. 
 
ExclusionCriteria 
Details  Participants with known visual or hearing impairments that limit the use of virtual reality.
Participants with a history of seizures, vertigo, or motion sickness triggered by virtual reality exposure.
Participants undergoing emergency coronary angiography.
Participants with cognitive impairment or psychiatric illness that affects comprehension.
Participants who have already received structured preoperative counselling using audiovisual or virtual reality methods. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in preoperative anxiety levels as measured by the State-Trait Anxiety Inventory (STAI) score, along with the maintenance of stable hemodynamic parameters.  Baseline (Pre-intervention):
The baseline assessment will be conducted before the patient receives any preparatory information, counselling, or exposure to the VR intervention—at the stage when the patient has been scheduled for coronary angiography and is awaiting the procedure. This captures the patient’s natural preoperative anxiety level and unmodified hemodynamic status.

Post-intervention:
The post-intervention assessment will be conducted immediately after the VR-based preoperative information session, before the patient is taken for coronary angiography, to determine the immediate effect of the intervention on anxiety and hemodynamic parameters. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [omveeru007@gmail.com].

  6. For how long will this data be available start date provided 22-12-2025 and end date provided 10-03-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study aims to evaluate the effectiveness of virtual reality based preoperative information on anxiety levels and hemodynamic parameters among patients undergoing coronary angiography at a selected hospital in Mangaluru, India. Coronary angiography is an important diagnostic procedure for heart disease, but it often causes significant anxiety, which can negatively affect physiological parameters such as blood pressure, heart rate, and oxygen saturation.

The study will use a true experimental design with pre-test and post-test control groups. A total of 104 participants meeting inclusion criteria will be randomly assigned to either the experimental group, which will receive a virtual reality session providing immersive preoperative information, or the control group, which will receive standard preoperative care. Anxiety levels will be measured using the State-Trait Anxiety Inventory (STAI), and hemodynamic parameters will be recorded before and after the intervention.

The findings are expected to determine whether virtual reality can effectively reduce preoperative anxiety and maintain stable hemodynamic status, potentially improving patient experience and outcomes during coronary angiography.

 
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